Liver Transplant; ComplicationsEVOLVENCT05951231
Liver Transplantation After ex Vivo Liver Perfusion
A study testing Liver transplantation in people with Liver Transplant; Complications and Transplant; Failure, Liver, run by Oslo University Hospital.
Trial summary
Today, it is difficult to predict liver function after transplantation and therefore livers where poor function is assumed (marginal livers) become discarded. The study aim is to increase the number of available donor livers, especially for liver cancer patients, by pre-treating and testing marginal ones (extended… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Liver Transplant; Complications, Transplant; Failure, Liver, Transplant Dysfunction
- What is being tested?
- Liver transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- ≥ 18 years
- Indication for liver transplantation (one criteria must be met):
- Colorectal cancer patients who have received 1st and 2nd line chemotherapy where the treatment has been stopped due to progression or toxicity and the patient is not eligible for SECA-2 (Survival Following Liver Transplantation for Patients With Nonresectable Liver-only Colorectal Metastases) study.
- Hepatocellular carcinoma patients who are not suitable for standard liver transplantation, liver resection or local treatment (Transarterial Chemoembolisation or Selective internal radiotherapy). The patients must have progression or intolerance (toxicity) for immune checkpoint inhibitors or 1st line treatment.
- Cholangiocarcinoma patients who have progression or intolerance to first-line chemotherapy.
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- Benign liver disease with urgent need for transplantation within months, but no regular graft is available.
- Life expectancy ≤ 6 months
- Willing, able and expected cooperation to attend follow-up examinations
- Patients who have a need for liver transplantation but cannot participate in other transplant studies or participation in another clinical trial with randomization to liver transplantation.
- For malignant disease the following criteria must be met:
- Good performance status assessed at the discretion of the treating physician.
- ECOG (Eastern Cooperative Oncology Group) 0 or 1
- Satisfactory blood tests
- Hemoglobin >8 g/dl
- Neutrophiles >1.0 (after any Granulocyte colony-stimulating factor)
- Platelets >75
- Bilirubin <1.5 x upper normal level
- ASAT (Aspartate aminotransferase), ALAT (alanine aminotransferase) <5 x upper normal level
- Albumin above lower normal level.
Who cannot join
- Already listed for ordinary Ltx with expectance of getting offered a regular liver graft within a reasonable time-frame.
- Patients included in the control arm of the SECA-3 study or the Excalibur studies except for the Ltx arm of the Excalibur I study.
- Mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial.
- Any reason why, in the opinion of the investigator, the patient should not participate.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Liver Transplantation After ex Vivo Liver Perfusion - The EVOLVE Study
Today, it is difficult to predict liver function after transplantation and therefore livers where poor function is assumed (marginal livers) become discarded. The study aim is to increase the number of available donor livers, especially for liver cancer patients, by pre-treating and testing marginal ones (extended criteria donor (ECD) livers) liver on a liver perfusion machine. A liver perfusion machine can simulate liver transplantation and enables functional/quality testing before transplantation. The machine will hopefully also make marginal livers more functional by reducing ischemia- \& reperfusion injury. A marginal donor liver is perfused ex situ with oxygenated blood from a blood donor on a machine. The liver can be tested here for function using internationally recognized criteria. At the same time, the investigators will carry out analyzes with microdialysis which can give a better picture of organ function and damage. Additionally, various samples of the liver and perfusate will be collected. Liver that achieves criteria for transplantation will be offered to the recipient.
Read the detailed description
The study is a single-center, prospective, open-label cohort study designed to determine the efficacy of liver perfusion of marginal ECD livers on a perfusion machine before liver transplantation. Donor livers will be preserved with standard cooling followed by three perfusion modes (Dual hypothermic oxygenated machine perfusion (DHOPE) / Controlled oxygenated rewarming (COR) / Normothermic machine perfusion (NMP)), a method used internationally to pre-treating marginal livers before liver transplantation and which able testing of function and quality before a transplantation is performed. Only livers that fulfill international criteria (Groningen criteria) will be approved for Ltx. In this study microdialysis will be used to monitoring the liver during machine perfusion and up to 14 days in the postoperative course to monitor the function of the liver. The hypothesis is that microdialysis will provide a better prediction of liver function than the existing Groeningen criteria. The investigators expect that most included patients, who receive ECD livers perfused on a machine, will receive a postoperative well-functioning liver graft which entails a significant survival benefit. The study is designed as a cohort study because included patients have a very poor prognosis (median overall survival of approx. 6 months) and others treatment options are lacking. The primary objective is to establish definitive, objective criteria for pre-transplant liver function by defining a threshold value for microdialysis parameters (especially lactate) between donor livers that will restore function and those that will not during ex vivo machine perfusion in ECD livers, which are superior to established criteria (Groeningen and Viability testing and transplantation of marginal livers (VITTAL) criteria)). The primary endpoint is microdialysis lactate level between donor livers after 4 hours of normothermic machine perfusion in ECD livers.
The follow-up period is 12 months.
- Conditions
- Liver Transplant; Complications, Transplant; Failure, Liver, Transplant Dysfunction, Transplant; Complication, Rejection, Transplant, Liver Metastases
- Being tested
- Liver transplantation
- Keywords
- Liver, Transplantation, Perfusion, Dual-end-ischemic Hypothermic Oxygenated Perfusion, Normothermic Machine Perfusion, Controlled Oxygenated Rewarming, Microdialysis
- Medical subject headings
- Rejection, Psychology, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver transplantationProcedure or surgery
Patients who receive an ECD liver after an ex-vivo liver perfusion where the liver has been tested for function and approved according to international functional criteria (Groeningen criteria)
| Study group | Role | What they receive |
|---|---|---|
| Liver transplanted patient | Active comparator | Patients who are transplanted with an ECD liver after pretreatment with a liver perfusion machine Receives: Procedure: Liver transplantation |
| Non-liver transplanted patient | No intervention | Patients who are not offered a liver transplantation during the inclusion period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactate level in microdialysate from hilar plate after normothermic machine perfusion - 4 hours
Lactate level in microdialysate from hilar plate after normothermic machine perfusion in extended criteria donors livers.
Measured: 4 hours
Secondary outcomes (303)
Lactate level in microdialysate from liver tissue after normothermic machine perfusion - 2.5 hours
Microdialysis lactate level in donor liver tissue after 2.5 hours of normothermic machine perfusion in extended criteria donors livers.
Measured: 2.5 hours
Lactate level in microdialysate from liver tissue after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
Microdialysis lactate level in donor liver tissue after 2 hours of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Measured: 2 hours
Pyruvate level in microdialysate from liver tissue after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
Microdialysis pyruvate level in donor liver tissue after 2 hours of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Measured: 2 hours
Glycerol level in microdialysate from liver tissue after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
Microdialysis glycerol level in donor liver tissue after 2 hours of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Measured: 2 hours
Glucose level in microdialysate from liver tissue after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
Microdialysis glucose level in donor liver tissue after 2 hours of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Measured: 2 hours
Lactate level in microdialysate from liver tissue after controlled oxygenated rewarming machine perfusion - 1 hour
Microdialysis lactate level in donor livers tissue after 1 hour of controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Measured: 1 hour
Glycerol level in microdialysate from liver tissue after controlled oxygenated rewarming machine perfusion - 1 hour
Microdialysis glycerol level in donor livers tissue after 1 hour of controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Measured: 1 hour
Glucose level in microdialysate from liver tissue after controlled oxygenated rewarming machine perfusion - 1 hour
Microdialysis glucose level in donor livers tissue after 1 hour of controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Measured: 1 hour
Pyruvate level in microdialysate from liver tissue after controlled oxygenated rewarming machine perfusion - 1 hour
Microdialysis pyruvate level in donor livers tissue after 1 hour of controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Measured: 1 hour
Glucose level in microdialysate from liver tissue after normothermic machine perfusion - 2.5 hours
Microdialysis glucose level in donor liver tissue after 2.5 hours of normothermic machine perfusion in extended criteria donors livers.
Measured: 2.5 hours
Glucose level in microdialysate from liver tissue after normothermic machine perfusion - 4 hours
Microdialysis glucose level in donor liver tissue after 4 hours of normothermic machine perfusion in extended criteria donors livers.
Measured: 4 hours
Pyruvate level in microdialysate from liver tissue after normothermic machine perfusion - 2.5 hours
Microdialysis pyruvate level in donor liver tissue after 2.5 hours of normothermic machine perfusion in extended criteria donors livers.
Measured: 2.5 hours
Pyruvate level in microdialysate from liver tissue after normothermic machine perfusion - 4 hours
Microdialysis pyruvate level in donor liver tissue after 4 hours of normothermic machine perfusion in extended criteria donors livers.
Measured: 4 hours
Glycerol level in microdialysate from liver tissue after normothermic machine perfusion - 2.5 hours
Microdialysis glycerol level in donor liver tissue after 2.5 hours of normothermic machine perfusion in extended criteria donors livers.
Measured: 2.5 hours
Glycerol level in microdialysate from liver tissue after normothermic machine perfusion - 4 hours
Microdialysis glycerol level in donor liver tissue after 4 hours of normothermic machine perfusion in extended criteria donors livers.
Measured: 4 hours
Lactate level in microdialysate from bile after normothermic machine perfusion - 4 hours
Microdialysis lactate level from bile after normothermic machine perfusion - 4 hours in extended criteria donors livers.
Measured: 4 hours
Lactate level in microdialysate from bile after normothermic machine perfusion - 2.5 hours
Microdialysis lactate level from bile after normothermic machine perfusion - 2.5 hours in extended criteria donors livers.
Measured: 2.5 hours
Glucose level in microdialysate from bile after normothermic machine perfusion - 4 hours
Microdialysis glucose levels from bile after normothermic machine perfusion - 4 hours in extended criteria donors livers.
Measured: 4 hours
Glucose level in microdialysate from bile after normothermic machine perfusion - 2.5 hours
Microdialysis glucose levels from bile after normothermic machine perfusion - 2.5 hours in extended criteria donors livers.
Measured: 2.5 hours
Pyruvate level in microdialysate from bile after normothermic machine perfusion - 4 hours
Microdialysis pyruvate levels from bile after normothermic machine perfusion - 4 hours in extended criteria donors livers.
Measured: 4 hours
Pyruvate level in microdialysate from bile after normothermic machine perfusion - 2.5 hours
Microdialysis pyruvate levels from bile after normothermic machine perfusion - 2.5 hours in extended criteria donors livers.
Measured: 2.5 hours
Glycerol level in microdialysate from bile after normothermic machine perfusion - 4 hours
Glycerol levels from bile after normothermic machine perfusion - 4 hours in extended criteria donors livers.
Measured: 4 hours
Glycerol level in microdialysate from bile after normothermic machine perfusion - 2.5 hours
Glycerol levels from bile after normothermic machine perfusion - 2.5 hours in extended criteria donors livers.
Measured: 2.5 hours
Glycerol level in microdialysate from bile after controlled oxygenated rewarming machine perfusion - 1 hour
Glycerol levels from bile after controlled oxygenated rewarming machine perfusion - 1 hour - in extended criteria donors livers.
Measured: 1 hour
Glucose level in microdialysate from bile after controlled oxygenated rewarming machine perfusion - 1 hour
Glucose levels from bile after controlled oxygenated rewarming machine perfusion - 1 hour - in extended criteria donors livers.
Measured: 1 hour
Lactate level in microdialysate from bile after controlled oxygenated rewarming machine perfusion - 1 hour
Lactate levels from bile after controlled oxygenated rewarming machine perfusion - 1 hour - in extended criteria donors livers.
Measured: 1 hour
Pyruvate level in microdialysate from bile after controlled oxygenated rewarming machine perfusion - 1 hour
Pyruvate levels from bile after controlled oxygenated rewarming machine perfusion - 1 hour - in extended criteria donors livers.
Measured: 1 hour
Pyruvate level in microdialysate from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
Pyruvate levels from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours - in extended criteria donors livers.
Measured: 2 hours
Glycerol level in microdialysate from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
Glycerol levels from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours - in extended criteria donors livers.
Measured: 2 hours
Lactate level in microdialysate from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
Lactate levels from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours - in extended criteria donors livers.
Measured: 2 hours
Glucose level in microdialysate from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
Glucose levels from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours - in extended criteria donors livers.
Measured: 2 hours
Bile gases pH - 4 hours after normothermic machine perfusion
Bile gas pH - 4 hours after normothermic machine perfusion in extended criteria donors livers.
Measured: 4 hours
Bile gases pH - 2.5 hours after normothermic machine perfusion
Bile gas pH - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
Measured: 2.5 hours
Bile gases Lactate - 4 hours after normothermic machine perfusion
Bile gas Lactate - 4 hours after normothermic machine perfusion in extended criteria donors livers.
Measured: 4 hours
Bile gases Lactate - 2.5 hours after normothermic machine perfusion
Bile gas Lactate - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
Measured: 2.5 hours
Bile gases Glucose - 4 hours after normothermic machine perfusion
Bile gas Glucose - 4 hours after normothermic machine perfusion in extended criteria donors livers.
Measured: 4 hours
Bile gases Glucose - 2.5 hours after normothermic machine perfusion
Bile gas Glucose - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
Measured: 2.5 hours
Bile gases Oxygen (O2) - 4 hours after normothermic machine perfusion
Bile gas O2 - 4 hours after normothermic machine perfusion in extended criteria donors livers.
Measured: 4 hours
Bile gases O2 - 2.5 hours after normothermic machine perfusion
Bile gas O2 - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
Measured: 2.5 hours
Bile gases carbon dioxide (CO2) - 4 hours after normothermic machine perfusion
Bile gas CO2 - 4 hours after normothermic machine perfusion in extended criteria donors livers.
Measured: 4 hours
Bile gases CO2 - 2.5 hours after normothermic machine perfusion
Bile gas CO2 - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
Measured: 2.5 hours
Bile gases bicarbonate (HCO3) - 4 hours after normothermic machine perfusion
Bile gas HCO3 - 4 hours after normothermic machine perfusion in extended criteria donors livers.
Measured: 4 hours
Bile gases HCO3 - 2.5 hours after normothermic machine perfusion
Bile gas HCO3 - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
Measured: 2.5 hours
Bile gases base excess (BE) - 4 hours after normothermic machine perfusion
Bile gas BE - 4 hours after normothermic machine perfusion in extended criteria donors livers.
Measured: 4 hours
Ischemia/reperfusion injury - 4 hours after normothermic machine perfusion
Ischemia/reperfusion injury in liver biopsies, graded according to Ali JM et al, Liver transplant 2015; nil, mild, moderate, and severe. - 4 hours after normothermic machine perfusion in extended criteria donors livers.
Measured: 4 hours
Ischemia/reperfusion damage - 4 hours after normothermic machine perfusion
Ischemia/reperfusion damage in liver biopsies, graded according to Suzuki score (Tian Y et al, Stem Cell Research \& Therapy, 2016); score 0, 1, 2, 3, (0=none, 4= severe) - 4 hours after normothermic machine perfusion in extended criteria donors livers.
Measured: 4 hours
Ischemia/reperfusion injury - after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
Ischemia/reperfusion injury in liver biopsies, graded according to Tian Y et al et al, Liver transplant 2015; nil, mild, moderate, and severe. - after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Measured: 4 hours
Ischemia/reperfusion damage - after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
Ischemia/reperfusion damage in liver biopsies, graded according to Suzuki score (Tian Y et al, Stem Cell Research \& Therapy, 2016); score 0, 1, 2, 3, (0=none, 4= severe) - after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Measured: 4 hours
Ischemia/reperfusion injury - before machine perfusion
Ischemia/reperfusion injury in liver biopsies, graded according to Ali JM et al, Liver transplant 2015; nil, mild, moderate, and severe. - before machine perfusion in extended criteria donors livers
Measured: 1 minute
Ischemia/reperfusion damage - before machine perfusion
Ischemia/reperfusion damage in liver biopsies, graded according to Suzuki score (Tian Y et al, Stem Cell Research \& Therapy, 2016); score 0, 1, 2, 3, (0=none, 4= severe) - before machine perfusion in extended criteria donors livers
Measured: 1 minute
Ischemia/reperfusion injury - after controlled oxygenated rewarming machine perfusion - 1 hour
Ischemia/reperfusion injury in liver biopsies, graded according to Ali JM et al, Liver transplant 2015; nil, mild, moderate, and severe - after controlled oxygenated rewarming machine perfusion - 1 hour in extended criteria donors livers
Measured: 1 hour
Ischemia/reperfusion damage - after controlled oxygenated rewarming machine perfusion - 1 hour
Ischemia/reperfusion damage in liver biopsies, graded according to Suzuki score (Tian Y et al, Stem Cell Research \& Therapy, 2016); score 0, 1, 2, 3, (0=none, 4= severe) - after controlled oxygenated rewarming machine perfusion - 1 hour in extended criteria donors livers
Measured: 1 hour
Ischemia/reperfusion injury - 2.5 hours after normothermic machine perfusion
Ischemia/reperfusion injury in liver biopsies, graded according to Ali JM et al, Liver transplant 2015; nil, mild, moderate, and severe. - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
Measured: 2.5 hours
Ischemia/reperfusion damage - 2.5 hours after normothermic machine perfusion
Ischemia/reperfusion damage in liver biopsies, graded according to Suzuki score (Tian Y et al, Stem Cell Research \& Therapy, 2016); score 0, 1, 2, 3, (0=none, 4= severe) - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
Measured: 2.5 hours
Bile gases BE - 2.5 hours after normothermic machine perfusion
Bile gas BE - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
Measured: 2.5 hours
Bile gases oxygen saturation (SO2) - 4 hours after normothermic machine perfusion
Bile gas SO2- 4 hours after normothermic machine perfusion in extended criteria donors livers.
Measured: 4 hours
Bile gases SO2 - 2.5 hours after normothermic machine perfusion
Bile gas SO2- 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
Measured: 2.5 hours
Bile gases hemoglobin (Hb)- 4 hours after normothermic machine perfusion
Bile gas Hb - 4 hours after normothermic machine perfusion in extended criteria donors livers.
Measured: 4 hours
Bile gases Hb - 2.5 hours after normothermic machine perfusion
Bile gas Hb - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
Measured: 2.5 hours
Bile gases sodium (Na) - 4 hours after normothermic machine perfusion
Bile gas Na - 4 hours after normothermic machine perfusion in extended criteria donors livers.
Measured: 4 hours
Bile gases Na - 2.5 hours after normothermic machine perfusion
Bile gas Na - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
Measured: 2.5 hours
Bile gases potassium (K) - 4 hours after normothermic machine perfusion
Bile gas K - 4 hours after normothermic machine perfusion in extended criteria donors livers.
Measured: 4 hours
Bile gases K - 2.5 hours after normothermic machine perfusion
Bile gas K - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
Measured: 2.5 hours
Bile gases Calcium (Ca) - 4 hours after normothermic machine perfusion
Bile gas Ca - 4 hours after normothermic machine perfusion in extended criteria donors livers.
Measured: 4 hours
Bile gases Ca - 2.5 hours after normothermic machine perfusion
Bile gas Ca - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
Measured: 2.5 hours
Markers of injury, inflammation - 2.5 hours after normothermic machine perfusion
Markers of injury, inflammation - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
Measured: 2.5 hours
Bile gas lactate 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
Bile gas lactate 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Measured: 2 hours
Markers of injury, inflammation 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
Markers of injury, inflammation 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Measured: 2 hours
Bile gas Glucose 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
Bile gas Glucose 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Measured: 2 hours
Bile gas pH 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
Bile gas pH 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Measured: 2 hours
Bile gas O2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
Bile gas O2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Measured: 2 hours
Bile gas CO2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
Bile gas CO2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Measured: 2 hours
Bile gas HCO3 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
Bile gas HCO3 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Measured: 2 hours
Bile gas SO2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
Bile gas SO2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Measured: 2 hours
Bile gas Hemoglobin 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
Bile gas Hemoglobin 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Measured: 2 hours
Bile gas Na 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
Bile gas Na 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Measured: 2 hours
Bile gas K 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
Bile gas K 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Measured: 2 hours
Bile gas Ca 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
Bile gas Ca 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Measured: 2 hours
Bile gas BE 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
Bile gas BE 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Measured: 2 hours
Markers of injury, inflammation 1 hour after controlled oxygenated rewarming machine perfusion
Markers of injury, inflammation 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Measured: 1 hour
Bile gas lactate 1 hour after controlled oxygenated rewarming machine perfusion
Bile gas lactate 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Measured: 1 hours
Bile gas Glucose 1 hour after controlled oxygenated rewarming machine perfusion
Bile gas Glucose 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Measured: 1 hours
Bile gas pH 1 hour after controlled oxygenated rewarming machine perfusion
Bile gas pH 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Measured: 1 hours
Markers of injury, inflammation 1 hour after controlled oxygenated rewarming machine perfusion
Markers of injury, inflammation 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Measured: 1 hours
Bile gas O2 1 hour after controlled oxygenated rewarming machine perfusion
Bile gas O2 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Measured: 1 hours
Bile gas CO2 1 hour after controlled oxygenated rewarming machine perfusion
Bile gas CO2 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Measured: 1 hours
Bile gas HCO3 1 hour after controlled oxygenated rewarming machine perfusion
Bile gas HCO3 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Measured: 1 hours
Bile gas BE 1 hour after controlled oxygenated rewarming machine perfusion
Bile gas BE 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Measured: 1 hours
Bile gas SO2 1 hour after controlled oxygenated rewarming machine perfusion
Bile gas SO2 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Measured: 1 hours
Bile gas hemoglobin 1 hour after controlled oxygenated rewarming machine perfusion
Bile gas hemoglobin 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Measured: 1 hours
Bile gas Na 1 hour after controlled oxygenated rewarming machine perfusion
Bile gas Na 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Measured: 1 hours
Bile gas K 1 hour after controlled oxygenated rewarming machine perfusion
Bile gas K 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Measured: 1 hours
Bile gas Ca 1 hour after controlled oxygenated rewarming machine perfusion
Bile gas Ca 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Measured: 1 hours
Perfusate gas Ca - during machine perfusion
Perfusate gas Ca during machine perfusion in extended criteria donors livers.
Measured: 24 hours
Perfusate gas pH - during machine perfusion
Perfusate gas pH during machine perfusion in extended criteria donors livers.
Measured: 24 hours
Perfusate gas SO2 - during machine perfusion
Perfusate gas SO2 during machine perfusion in extended criteria donors livers.
Measured: 24 hours
Perfusate gas O2 - during machine perfusion
Perfusate gas O2 during machine perfusion in extended criteria donors livers.
Measured: 24 hours
Perfusate gas CO2 - during machine perfusion
Perfusate gas CO2 during machine perfusion in extended criteria donors livers.
Measured: 24 hours
Perfusate gas K - during machine perfusion
Perfusate gas K during machine perfusion in extended criteria donors livers.
Measured: 24 hours
Perfusate gas Na - during machine perfusion
Perfusate gas Na during machine perfusion in extended criteria donors livers.
Measured: 24 hours
Perfusate gas BE - during machine perfusion
Perfusate gas BE during machine perfusion in extended criteria donors livers.
Measured: 24 hours
Perfusate gas HCO3 - during machine perfusion
Perfusate gas HCO3 during machine perfusion in extended criteria donors livers.
Measured: 24 hours
Perfusate gas hemoglobin - during machine perfusion
Perfusate gas hemoglobin during machine perfusion in extended criteria donors livers.
Measured: 24 hours
Perfusate gas lactate - during machine perfusion
Perfusate gas lactate during machine perfusion in extended criteria donors livers.
Measured: 24 hours
Perfusate gas glucose - during machine perfusion
Perfusate gas glucose during machine perfusion in extended criteria donors livers.
Measured: 24 hours
Postoperative complications
According to Clavien Dindo Classification
Measured: 12 months
Length of stay
Length of initial ICU and initial hospital stay is determined in days of admission following liver transplantation.
Measured: 4 months
Machine flow during controlled oxygenated rewarming
Machine flow (millilitre/hour)
Measured: 1 hour
Machine flow during Dual-end-ischemic Hypothermic Oxygenated Perfusion
Machine flow (millilitre/hour)
Measured: 1 hour
Machine pressure during controlled oxygenated rewarming
Machine pressure ((millimetre Hg))
Measured: 1 hour
Machine pressure during Dual-end-ischemic Hypothermic Oxygenated Perfusion
Machine pressure ((millimetre Hg))
Measured: 1 hour
Machine Fraction of oxygen during controlled oxygenated rewarming
Machine fraction of oxygen (%)
Measured: 1 hour
Machine Fraction of oxygen Dual-end-ischemic Hypothermic Oxygenated Perfusion
Machine fraction of oxygen (%)
Measured: 1 hour
Machine Resistance during controlled oxygenated rewarming
Machine Resistance (millilitre/minute/millimetre Hg)
Measured: 1 hour
Machine Resistance during Dual-end-ischemic Hypothermic Oxygenated Perfusion
Machine Resistance (millilitre/minute/millimetre Hg)
Measured: 1 hour
Machine flow during Dual-end-ischemic Hypothermic Oxygenated Perfusion
Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion flow (millilitre/hour)
Measured: 2 hours
Machine flow during normothermic machine perfusion
Machine flow during normothermic machine perfusion (millilitre/hour)
Measured: 4 hours
Machine flow during normothermic machine perfusion
Machine flow during normothermic machine perfusion (millilitre/hour)
Measured: 2.5 hours
Machine pressure during normothermic machine perfusion
Machine pressure (millimetre Hg)
Measured: 4 hours
Machine pressure during normothermic machine perfusion
Machine pressure (millimetre Hg)
Measured: 2.5 hours
Machine Fraction of oxygen during normothermic machine perfusion
Machine fraction of oxygen (%)
Measured: 4 hours
Machine Fraction of oxygen during normothermic machine perfusion
Machine fraction of oxygen (%)
Measured: 2.5 hours
Machine Resistance during normothermic machine perfusion
Machine Resistance (millilitre/minute/millimetre Hg)
Measured: 4 hours
Machine Resistance during normothermic machine perfusion
Machine Resistance (millilitre/minute/millimetre Hg)
Measured: 2.5 hours
Total preservation time
Total preservation time (machine perfusion time)
Measured: 48 hours
Alanine amino transferase in perfusate during machine perfusion
Alanine amino transferase in perfusate during machine perfusion (U/Litre)
Measured: 24 hours
Aspartate amino transferase in perfusate during machine perfusion
Aspartate amino transferase in perfusate during machine perfusion (U/Litre)
Measured: 24 hours
Alkaline phosphatase in perfusate during machine perfusion
Aspartate amino transferase in perfusate during machine perfusion (U/Litre)
Measured: 24 hours
Gamma-glutamyl transferase in perfusate during machine perfusion
Gamma-glutamyl transferase in perfusate during machine perfusion (U/Litre)
Measured: 24 hours
Urea in perfusate during machine perfusion
Urea in perfusate during machine perfusion (millimol/Litre)
Measured: 24 hours
Bilirubin in perfusate during machine perfusion
Bilirubin in perfusate during machine perfusion (micromol/Litre)
Measured: 24 hours
Not yet decided types of cytokines/interleukins, endothelium markers, miRNA's in perfusate during machine perfusion
Different cytokines/interleukins, endothelium markers, miRNA's in perfusate during machine perfusion
Measured: 24 hours
Not yet decided types of cytokines/interleukins, endothelium markers, miRNA's in liver tissue during machine perfusion
Different cytokines/interleukins, endothelium markers, miRNA's in liver tissue during machine perfusion
Measured: 24 hours
Not yet decided types of cytokines/interleukins, endothelium markers, miRNA's in bile during machine perfusion
Different cytokines/interleukins, endothelium markers, miRNA's in bile during machine perfusion
Measured: 24 hours
Histopathology - liver tissue. Mitochondrial function
Histological analysis of parenchymal biopsies which are assessed for mitochondrial function.
Measured: During machine perfusion - 24 hours
Histopathology - bile duct. Mitochondrial function
Histological analysis of bile duct biopsies which are assessed for mitochondrial function.
Measured: During machine perfusion - 24 hours
Histopathology - liver tissue. Perfusion/reperfusion injury
Histological analysis of parenchymal biopsies which are assessed for perfusion/reperfusion injury
Measured: During machine perfusion - 24 hours
Histopathology - bile duct. Perfusion/reperfusion injury
Histological analysis of bile duct biopsies which are assessed for perfusion/reperfusion injury
Measured: During machine perfusion - 24 hours
Histopathology - liver tissue. Cell death
Histological analysis of parenchymal biopsies which are assessed for cell death
Measured: During machine perfusion - 24 hours
Histopathology - bile duct. Cell death
Histological analysis of bile duct biopsies which are assessed for cell death
Measured: During machine perfusion - 24 hours
Histopathology - liver tissue. Inflammation
Histological analysis of parenchymal biopsies which are assessed for inflammation
Measured: During machine perfusion - 24 hours
Histopathology - bile duct. Inflammation
Histological analysis of bile duct biopsies which are assessed for inflammation
Measured: During machine perfusion - 24 hours
Histopathology - liver tissue. Metabolomics
Histological analysis of parenchymal biopsies which are assessed for metabolomics
Measured: During machine perfusion - 24 hours
Histopathology - bileduct. Metabolomics
Histological analysis of bile duct biopsies which are assessed for metabolomics
Measured: During machine perfusion - 24 hours
Histopathology - liver tissue. Lipidomics
Histological analysis of parenchymal biopsies which are assessed for lipidomics
Measured: During machine perfusion - 24 hours
Histopathology - bile duct. Lipidomics
Histological analysis of bile duct biopsies which are assessed for lipidomics
Measured: During machine perfusion - 24 hours
Histopathology - liver tissue. RNA sequencing
Histological analysis of parenchymal biopsies which are assessed for RNA sequencing
Measured: During machine perfusion - 24 hours
Histopathology - bile duct. RNA sequencing
Histological analysis of bile duct biopsies which are assessed for RNA sequencing
Measured: During machine perfusion - 24 hours
Histopathology - liver tissue. Endothelium properties
Histological analysis of parenchymal biopsies which are assessed for endothelium properties
Measured: During machine perfusion - 24 hours
Histopathology - bile duct. Endothelium properties
Histological analysis of bile duct biopsies which are assessed for endothelium properties
Measured: During machine perfusion - 24 hours
International normalized ratio on postoperative day 7
Blood sample from recipient: International normalized ratio on postoperative day 7
Measured: 7 postoperative day
Alanine amino transferase postoperative day 0
Alanine amino transferase postoperative day 0 in the donated recipients (U/Litre)
Measured: Postoperative day 0
Aspartate amino transferase postoperative day 0
Aspartate amino transferase postoperative day 0 in the donated recipients (U/Litre)
Measured: Postoperative day 0
Alkaline phosphatase postoperative day 0
Alkaline phosphatase postoperative day 0 in the donated recipients (U/Litre)
Measured: Postoperative day 0
Gamma-glutamyl transferase postoperative day 0
Gamma-glutamyl transferase postoperative day 0 in the donated recipients (U/Litre)
Measured: Postoperative day 0
Urea postoperative day 0
Urea postoperative day 0 in the donated recipients (millimol/Litre)
Measured: Postoperative day 0
Bilirubin postoperative day 0
Bilirubin postoperative day 0 in the donated recipients (micromol/Litre)
Measured: Postoperative day 0
Bilirubin postoperative day 1
Bilirubin postoperative day 1 in the donated recipients (micromol/Litre)
Measured: Postoperative day 1
Bilirubin postoperative day 2
Bilirubin postoperative day 2 in the donated recipients (micromol/Litre)
Measured: Postoperative day 2
Bilirubin postoperative day 3
Bilirubin postoperative day 3 in the donated recipients (micromol/Litre)
Measured: Postoperative day 3
Bilirubin postoperative day 4
Bilirubin postoperative day 4 in the donated recipients (micromol/Litre)
Measured: Postoperative day 4
Bilirubin postoperative day 5
Bilirubin postoperative day 5 in the donated recipients (micromol/Litre)
Measured: Postoperative day 5
Bilirubin postoperative day 6
Bilirubin postoperative day 6 in the donated recipients (micromol/Litre)
Measured: Postoperative day 6
Bilirubin postoperative day 7
Bilirubin postoperative day 7 in the donated recipients (micromol/Litre)
Measured: Postoperative day 7
Urea postoperative day 1
Urea postoperative day 1 in the donated recipients (millimol/Litre)
Measured: Postoperative day 1
Urea postoperative day 2
Urea postoperative day 2 in the donated recipients (millimol/Litre)
Measured: Postoperative day 2
Urea postoperative day 3
Urea postoperative day 3 in the donated recipients (millimol/Litre)
Measured: Postoperative day 3
Urea postoperative day 4
Urea postoperative day 4 in the donated recipients (millimol/Litre)
Measured: Postoperative day 4
Urea postoperative day 5
Urea postoperative day 5 in the donated recipients (millimol/Litre)
Measured: Postoperative day 5
Urea postoperative day 6
Urea postoperative day 6 in the donated recipients (millimol/Litre)
Measured: Postoperative day 6
Urea postoperative day 7
Urea postoperative day 7 in the donated recipients (millimol/Litre)
Measured: Postoperative day 7
Aspartate amino transferase postoperative day 1
Aspartate amino transferase postoperative day 1 in the donated recipients (U/Litre)
Measured: Postoperative day 1
Alkaline phosphatase postoperative day 1
Alkaline phosphatase postoperative day 1 in the donated recipients (U/Litre)
Measured: Postoperative day 1
Gamma-glutamyl transferase postoperative day 1
Gamma-glutamyl transferase postoperative day 1 in the donated recipients (U/Litre)
Measured: Postoperative day 1
Alanine amino transferase postoperative day 2
Alanine amino transferase postoperative day 2 in the donated recipients (U/Litre)
Measured: Postoperative day 2
Aspartate amino transferase postoperative day 2
Aspartate amino transferase postoperative day 2 in the donated recipients (U/Litre)
Measured: Postoperative day 2
Alkaline phosphatase postoperative day 2
Alkaline phosphatase postoperative day 2 in the donated recipients (U/Litre)
Measured: Postoperative day 2
Gamma-glutamyl transferase postoperative day 2
Gamma-glutamyl transferase postoperative day 2 in the donated recipients (U/Litre)
Measured: Postoperative day 2
Alanine amino transferase postoperative day 3
Alanine amino transferase postoperative day 3 in the donated recipients (U/Litre)
Measured: Postoperative day 3
Aspartate amino transferase postoperative day 3
Aspartate amino transferase postoperative day 3 in the donated recipients (U/Litre)
Measured: Postoperative day 3
Alkaline phosphatase postoperative day 3
Alkaline phosphatase postoperative day 3 in the donated recipients (U/Litre)
Measured: Postoperative day 3
Gamma-glutamyl transferase postoperative day 3
Gamma-glutamyl transferase postoperative day 3 in the donated recipients (U/Litre)
Measured: Postoperative day 3
Alanine amino transferase postoperative day 4
Alanine amino transferase postoperative day 4 in the donated recipients (U/Litre)
Measured: Postoperative day 4
Aspartate amino transferase postoperative day 4
Aspartate amino transferase postoperative day 4 in the donated recipients (U/Litre)
Measured: Postoperative day 4
Alkaline phosphatase postoperative day 4
Alkaline phosphatase postoperative day 4 in the donated recipients (U/Litre)
Measured: Postoperative day 4
Gamma-glutamyl transferase postoperative day 4
Gamma-glutamyl transferase postoperative day 4 in the donated recipients (U/Litre)
Measured: Postoperative day 4
Alanine amino transferase postoperative day 5
Alanine amino transferase postoperative day 5 in the donated recipients (U/Litre)
Measured: Postoperative day 5
Aspartate amino transferase postoperative day 5
Aspartate amino transferase postoperative day 5 in the donated recipients (U/Litre)
Measured: Postoperative day 5
Alkaline phosphatase postoperative day 5
Alkaline phosphatase postoperative day 5 in the donated recipients (U/Litre)
Measured: Postoperative day 5
Gamma-glutamyl transferase postoperative day 5
Gamma-glutamyl transferase postoperative day 5 in the donated recipients (U/Litre)
Measured: Postoperative day 5
Alanine amino transferase postoperative day 6
Alanine amino transferase postoperative day 6 in the donated recipients (U/Litre)
Measured: Postoperative day 6
Aspartate amino transferase postoperative day 6
Aspartate amino transferase postoperative day 6 in the donated recipients (U/Litre)
Measured: Postoperative day 6
Alkaline phosphatase postoperative day 6
Aspartate amino transferase postoperative day 6 in the donated recipients (U/Litre)
Measured: Postoperative day 6
Gamma-glutamyl transferase postoperative day 6
Gamma-glutamyl transferase postoperative day 6 in the donated recipients (U/Litre)
Measured: Postoperative day 6
Alanine amino transferase postoperative day 7
Alanine amino transferase postoperative day 7 in the donated recipients (U/Litre)
Measured: Postoperative day 7
Aspartate amino transferase postoperative day 7
Aspartate amino transferase postoperative day 7 in the donated recipients (U/Litre)
Measured: Postoperative day 7
Alkaline phosphatase postoperative day 7
Alkaline phosphatase postoperative day 7 in the donated recipients (U/Litre)
Measured: Postoperative day 7
Gamma-glutamyl transferase postoperative day 7
Gamma-glutamyl transferase postoperative day 7 in the donated recipients (U/Litre)
Measured: Postoperative day 7
Alanine amino transferase postoperative month 1
Alanine amino transferase postoperative month 1 in the donated recipients (U/Litre)
Measured: 1 month after surgery
Aspartate amino transferase postoperative month 1
Aspartate amino transferase postoperative month 1 in the donated recipients (U/Litre)
Measured: 1 month after surgery
Alkaline phosphatase postoperative month 1
Alkaline phosphatase postoperative month 1 in the donated recipients (U/Litre)
Measured: 1 month after surgery
Gamma-glutamyl transferase postoperative month 1
Gamma-glutamyl transferase postoperative month 1 in the donated recipients (U/Litre)
Measured: 1 month after surgery
Urea postoperative month 1
Urea postoperative month 1 in the donated recipients (millimol/Litre)
Measured: 1 month after surgery
Bilirubin postoperative month 1
Bilirubin postoperative month 1 in the donated recipients (micromol/Litre)
Measured: 1 month after surgery
Bilirubin postoperative month 2
Bilirubin postoperative month 2 in the donated recipients (micromol/Litre)
Measured: 2 month after surgery
Bilirubin postoperative month 3
Bilirubin postoperative month 3 in the donated recipients (micromol/Litre)
Measured: 3 month after surgery
Bilirubin postoperative month 4
Bilirubin postoperative month 4 in the donated recipients (micromol/Litre)
Measured: 4 month after surgery
Bilirubin postoperative month 5
Bilirubin postoperative month 5 in the donated recipients (micromol/Litre)
Measured: 5 month after surgery
Bilirubin postoperative month 6
Bilirubin postoperative month 6 in the donated recipients (micromol/Litre)
Measured: 6 month after surgery
Bilirubin postoperative month 7
Bilirubin postoperative month 7 in the donated recipients (micromol/Litre)
Measured: 7 month after surgery
Bilirubin postoperative month 8
Bilirubin postoperative month 8 in the donated recipients (micromol/Litre)
Measured: 8 month after surgery
Bilirubin postoperative month 9
Bilirubin postoperative month 9 in the donated recipients (micromol/Litre)
Measured: 9 month after surgery
Bilirubin postoperative month 10
Bilirubin postoperative month 10 in the donated recipients (micromol/Litre)
Measured: 10 month after surgery
Bilirubin postoperative month 11
Bilirubin postoperative month 11 in the donated recipients (micromol/Litre)
Measured: 11 month after surgery
Bilirubin postoperative month 12
Bilirubin postoperative month 12 in the donated recipients (micromol/Litre)
Measured: 12 month after surgery
Urea postoperative month 2
Urea postoperative month 2 in the donated recipients (millimol/Litre)
Measured: 2 month after surgery
Urea postoperative month 3
Urea postoperative month 3 in the donated recipients (millimol/Litre)
Measured: 3 month after surgery
Urea postoperative month 4
Urea postoperative month 4 in the donated recipients (millimol/Litre)
Measured: 4 month after surgery
Urea postoperative month 5
Urea postoperative month 5 in the donated recipients (millimol/Litre)
Measured: 5 month after surgery
Urea postoperative month 6
Urea postoperative month 6 in the donated recipients (millimol/Litre)
Measured: 6 month after surgery
Urea postoperative month 7
Urea postoperative month 7 in the donated recipients (millimol/Litre)
Measured: 7 month after surgery
Urea postoperative month 8
Urea postoperative month 8 in the donated recipients (millimol/Litre)
Measured: 8 month after surgery
Urea postoperative month 9
Urea postoperative month 9 in the donated recipients (millimol/Litre)
Measured: 9 month after surgery
Urea postoperative month 10
Urea postoperative month 10 in the donated recipients (millimol/Litre)
Measured: 10 month after surgery
Urea postoperative month 11
Urea postoperative month 11 in the donated recipients (millimol/Litre)
Measured: 11 month after surgery
Urea postoperative month 12
Urea postoperative month 12 in the donated recipients (millimol/Litre)
Measured: 12 month after surgery
Alanine amino transferase postoperative month 2
Alanine amino transferase postoperative month 2 in the donated recipients (U/Litre)
Measured: 2 month after surgery
Aspartate amino transferase postoperative month 2
Aspartate amino transferase postoperative month 2 in the donated recipients (U/Litre)
Measured: 2 month after surgery
Alkaline phosphatase postoperative month 2
Alkaline phosphatase postoperative month 2 in the donated recipients (U/Litre)
Measured: 2 month after surgery
Gamma-glutamyl transferase postoperative month 2
Gamma-glutamyl transferase postoperative month 2 in the donated recipients (U/Litre)
Measured: 2 month after surgery
Alanine amino transferase postoperative month 3
Alanine amino transferase postoperative month 3 in the donated recipients (U/Litre)
Measured: 3 month after surgery
Aspartate amino transferase postoperative month 3
Aspartate amino transferase postoperative month 3 in the donated recipients (U/Litre)
Measured: 3 month after surgery
Alkaline phosphatase postoperative month 3
Alkaline phosphatase postoperative month 3 in the donated recipients (U/Litre)
Measured: 3 month after surgery
Gamma-glutamyl transferase postoperative month 3
Gamma-glutamyl transferase postoperative month 3 in the donated recipients (U/Litre)
Measured: 3 month after surgery
Alanine amino transferase postoperative month 4
Alanine amino transferase postoperative month 4 in the donated recipients (U/Litre)
Measured: 4 month after surgery
Aspartate amino transferase postoperative month 4
Aspartate amino transferase postoperative month 4 in the donated recipients (U/Litre)
Measured: 4 month after surgery
Alkaline phosphatase postoperative month 4
Alkaline phosphatase postoperative month 4 in the donated recipients (U/Litre)
Measured: 4 month after surgery
Gamma-glutamyl transferase postoperative month 4
Gamma-glutamyl transferase postoperative month 4 in the donated recipients (U/Litre)
Measured: 4 month after surgery
Alanine amino transferase postoperative month 5
Alanine amino transferase postoperative month 5 in the donated recipients (U/Litre)
Measured: 5 month after surgery
Aspartate amino transferase postoperative month 5
Aspartate amino transferase postoperative month 5 in the donated recipients (U/Litre)
Measured: 5 month after surgery
Alkaline phosphatase postoperative month 5
Alkaline phosphatase postoperative month 5 in the donated recipients (U/Litre)
Measured: 5 month after surgery
Gamma-glutamyl transferase postoperative month 5
Gamma-glutamyl transferase postoperative month 5 in the donated recipients (U/Litre)
Measured: 5 month after surgery
Alanine amino transferase postoperative month 6
Alanine amino transferase postoperative month 6 in the donated recipients (U/Litre)
Measured: 6 month after surgery
Aspartate amino transferase postoperative month 6
Aspartate amino transferase postoperative month 6 in the donated recipients (U/Litre)
Measured: 6 month after surgery
Alkaline phosphatase postoperative month 6
Alkaline phosphatase postoperative month 6 in the donated recipients (U/Litre)
Measured: 6 month after surgery
Gamma-glutamyl transferase postoperative month 6
Gamma-glutamyl transferase postoperative month 6 in the donated recipients (U/Litre)
Measured: 6 month after surgery
Alanine amino transferase postoperative month 7
Alanine amino transferase postoperative month 7 in the donated recipients (U/Litre)
Measured: 7 month after surgery
Aspartate amino transferase postoperative month 7
Aspartate amino transferase postoperative month 7 in the donated recipients (U/Litre)
Measured: 7 month after surgery
Alkaline phosphatase postoperative month 7
Alkaline phosphatase postoperative month 7 in the donated recipients (U/Litre)
Measured: 7 month after surgery
Gamma-glutamyl transferase postoperative month 7
Gamma-glutamyl transferase postoperative month 7 in the donated recipients (U/Litre)
Measured: 7 month after surgery
Alanine amino transferase postoperative month 8
Alanine amino transferase postoperative month 8 in the donated recipients (U/Litre)
Measured: 8 month after surgery
Aspartate amino transferase postoperative month 8
Aspartate amino transferase postoperative month 8 in the donated recipients (U/Litre)
Measured: 8 month after surgery
Alkaline phosphatase postoperative month 8
Alkaline phosphatase postoperative month 8 in the donated recipients (U/Litre)
Measured: 8 month after surgery
Gamma-glutamyl transferase postoperative month 8
Gamma-glutamyl transferase postoperative month 8 in the donated recipients (U/Litre)
Measured: 8 month after surgery
Alanine amino transferase postoperative month 9
Alanine amino transferase postoperative month 9 in the donated recipients (U/Litre)
Measured: 9 month after surgery
Aspartate amino transferase postoperative month 9
Aspartate amino transferase postoperative month 9 in the donated recipients (U/Litre)
Measured: 9 month after surgery
Alkaline phosphatase postoperative month 9
Alkaline phosphatase postoperative month 9 in the donated recipients (U/Litre)
Measured: 9 month after surgery
Gamma-glutamyl transferase postoperative month 9
Gamma-glutamyl transferase postoperative month 9 in the donated recipients (U/Litre)
Measured: 9 month after surgery
Alanine amino transferase postoperative month 10
Alanine amino transferase postoperative month 10 in the donated recipients (U/Litre)
Measured: 10 month after surgery
Aspartate amino transferase postoperative month 10
Aspartate amino transferase postoperative month 10 in the donated recipients (U/Litre)
Measured: 10 month after surgery
Alkaline phosphatase postoperative month 10
Alkaline phosphatase postoperative month 10 in the donated recipients (U/Litre)
Measured: 10 month after surgery
Gamma-glutamyl transferase postoperative month 10
Gamma-glutamyl transferase postoperative month 10 in the donated recipients (U/Litre)
Measured: 10 month after surgery
Alanine amino transferase postoperative month 11
Alanine amino transferase postoperative month 11 in the donated recipients (U/Litre)
Measured: 11 month after surgery
Aspartate amino transferase postoperative month 11
Aspartate amino transferase postoperative month 11 in the donated recipients (U/Litre)
Measured: 11 month after surgery
Alkaline phosphatase postoperative month 11
Alkaline phosphatase postoperative month 11 in the donated recipients (U/Litre)
Measured: 11 month after surgery
Gamma-glutamyl transferase postoperative month 11
Gamma-glutamyl transferase postoperative month 11 in the donated recipients (U/Litre)
Measured: 11 month after surgery
Alanine amino transferase postoperative month 12
Alanine amino transferase postoperative month 12 in the donated recipients (U/Litre)
Measured: 12 month after surgery
Aspartate amino transferase postoperative month 12
Aspartate amino transferase postoperative month 12 in the donated recipients (U/Litre)
Measured: 12 month after surgery
Alkaline phosphatase postoperative month 12
Alkaline phosphatase postoperative month 12 in the donated recipients (U/Litre)
Measured: 12 month after surgery
Gamma-glutamyl transferase postoperative month 12
Gamma-glutamyl transferase postoperative month 12 in the donated recipients (U/Litre)
Measured: 12 month after surgery
Postoperative microdialysis levels of lactate
Postoperative microdialysis levels of lactate in transplanted livers the first 14 postoperative days
Measured: 14 days
Postoperative microdialysis levels of pyruvate
Postoperative microdialysis levels of pyruvate in transplanted livers the first 14 postoperative days
Measured: 14 days
Postoperative microdialysis levels of glycerol
Postoperative microdialysis levels of glycerol in transplanted livers the first 14 postoperative days
Measured: 14 days
Postoperative microdialysis levels of glucose
Postoperative microdialysis levels of glucose in transplanted livers the first 14 postoperative days
Measured: 14 days
Systolic blood pressure
Systolic blood pressure (millimeter Hg)
Measured: From 5 min before reperfusion, up to 20 minutes after reperfusion
Diastolic blood pressure
Diastolic blood pressure (millimeter Hg)
Measured: From 5 min before reperfusion, up to 20 minutes after reperfusion
Heart rate
Heart rate (Beats/minute)
Measured: From 5 min before reperfusion, up to 20 minutes after reperfusion
Vasopressor dosage
Vasopressor dosage (microgram/kilogram/minutes)
Measured: From 5 min before reperfusion, up to 20 minutes after reperfusion
Patient survival
Patient survival (days)
Measured: Through study completion, an average of 12 months
Graft survival
Graft (censored and uncensored for patient death) survival (days)
Measured: Through study completion, an average of 12 months
Number of deaths
Number of deaths first 7 days after transplantation
Measured: 7 days after transplantation
Number of retransplantation
Number of retransplantation first 7 days after transplantation
Measured: 7 days after transplantation
Incidens of new onset diabetes after transplantation
New onset diabetes after transplantation after transplantation. New onset diabetes after transplantation is defined according to the World Health Organization criteria (Report 2003 S5-20).
Measured: Through study completion, an average of 12 months
Estimated glomerular filtration rate - Renal function
Estimated glomerular filtration rate according to the 4-variable Modification of Diet in Renal Disease equation.
Measured: Through study completion, an average of 12 months
The incidence of symptomatic Non-anastomotic Biliary Strictures
The incidence of symptomatic non-anastomotic biliary strictures
Measured: 6 months
The incidence of asymptomatic Non-anastomotic Biliary Strictures
The incidence of asymptomatic non-anastomotic biliary strictures
Measured: 6 months
The incidence of asymptomatic Non-anastomotic Biliary Strictures
The incidence of asymptomatic non-anastomotic biliary strictures
Measured: 12 months
The incidence of symptomatic Non-anastomotic Biliary Strictures
The incidence of symptomatic non-anastomotic biliary strictures
Measured: 12 months
The severity of Non-anastomotic Biliary Strictures
The severity of Non-anastomotic Biliary Strictures based on a scoring system described by Buis et. al (mild, moderate, or severe)
Measured: Through study completion, an average of 12 months
The location of Non-anastomotic Biliary Strictures
The location of Non-anastomotic Biliary Strictures is assessed by images of the magnetic resonance cholangiopancreatography
Measured: Through study completion, an average of 12 months
The incidence of infections
The incidence of infections leading to administration of antibiotics/antifungal/antiviral treatment
Measured: Through study completion, an average of 12 months
Lactate level in microdialysate from liver tissue - 4 hours
Microdialysis lactate level in donor liver tissue after 4 hours of normothermic machine perfusion in extended criteria donors livers.
Measured: 4 hours
Pyruvate level in microdialysate from hilar plate after normothermic machine perfusion - 4 hours
Pyruvate level in microdialysate from hilar plate after normothermic machine perfusion in extended criteria donors livers.
Measured: 4 hours
Glycerol level in microdialysate from hilar plate after normothermic machine perfusion - 4 hours
Glycerol level in microdialysate from hilar plate after normothermic machine perfusion in extended criteria donors livers.
Measured: 4 hours
Glucose level in microdialysate from hilar plate after normothermic machine perfusion - 4 hours
Glucose level in microdialysate from hilar plate after normothermic machine perfusion in extended criteria donors livers.
Measured: 4 hours
Glycerol level in microdialysate from hilar plate after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
Glycerol level in microdialysate from hilar plate after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Measured: 2 hours
Lactate level in microdialysate from hilar plate after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
Lactate level in microdialysate from hilar plate after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Measured: 2 hours
Glucose level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion - 1 hour
Glucose level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Measured: 1 hour
Pyruvate level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion - 1 hour
Pyruvate level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Measured: 1 hour
Glycerol level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion - 1 hour
Glycerol level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Measured: 1 hour
Lactate level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion - 1 hour
Lactate level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
Measured: 1 hour
Glucose level in microdialysate from hilar plate after of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers - 2 hours
Glucose level in microdialysate from hilar plate after of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Measured: 2 hour
Pyruvate level in microdialysate from hilar plate after of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers - 2 hours
Pyruvate level in microdialysate from hilar plate after of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
Measured: 2 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study startFeb 2024 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Single center, prospective, open, observational study
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority
- Responsible party
- Principal investigator, Søren Erik Pischke, Oslo University Hospital
- Investigators
- Søren E Pischke, MD, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951231
- Sponsor's protocol ID
- 598448
- Acronym
- EVOLVE
- Status last verified
- Oct 2023
- First submitted
- 4 Apr 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to Norwegian laws individual participant data are not shared
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Transplantation After ex Vivo Liver Perfusion - The EVOLVE Study
- ClinicalTrials.gov ID
- NCT05951231
- Acronym / sponsor ID
- EVOLVE / 598448
- Conditions
- Liver Transplant; Complications, Transplant; Failure, Liver, Transplant Dysfunction, Transplant; Complication, Rejection, Transplant, Liver Metastases
- Keywords
- Liver, Transplantation, Perfusion, Dual-end-ischemic Hypothermic Oxygenated Perfusion, Normothermic Machine Perfusion, Controlled Oxygenated Rewarming, Microdialysis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority
- Study start
- Feb 2024 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Today, it is difficult to predict liver function after transplantation and therefore livers where poor function is assumed (marginal livers) become discarded. The study aim is to increase the number of available donor livers, especially for liver cancer patients, by pre-treating and testing marginal ones (extended criteria donor (ECD) livers) liver on a liver perfusion machine. A liver perfusion machine can simulate liver transplantation and enables functional/quality testing before transplantation. The machine will hopefully also make marginal livers more functional by reducing ischemia- \& reperfusion injury. A marginal donor liver is perfused ex situ with oxygenated blood from a blood donor on a machine. The liver can be tested here for function using internationally recognized criteria. At the same time, the investigators will carry out analyzes with microdialysis which can give a better picture of organ function and damage. Additionally, various samples of the liver and perfusate will be collected. Liver that achieves criteria for transplantation will be offered to the recipient.
Detailed description
The study is a single-center, prospective, open-label cohort study designed to determine the efficacy of liver perfusion of marginal ECD livers on a perfusion machine before liver transplantation. Donor livers will be preserved with standard cooling followed by three perfusion modes (Dual hypothermic oxygenated machine perfusion (DHOPE) / Controlled oxygenated rewarming (COR) / Normothermic machine perfusion (NMP)), a method used internationally to pre-treating marginal livers before liver transplantation and which able testing of function and quality before a transplantation is performed. Only livers that fulfill international criteria (Groningen criteria) will be approved for Ltx. In this study microdialysis will be used to monitoring the liver during machine perfusion and up to 14 days in the postoperative course to monitor the function of the liver. The hypothesis is that microdialysis will provide a better prediction of liver function than the existing Groeningen criteria. The investigators expect that most included patients, who receive ECD livers perfused on a machine, will receive a postoperative well-functioning liver graft which entails a significant survival benefit. The study is designed as a cohort study because included patients have a very poor prognosis (median overall survival of approx. 6 months) and others treatment options are lacking. The primary objective is to establish definitive, objective criteria for pre-transplant liver function by defining a threshold value for microdialysis parameters (especially lactate) between donor livers that will restore function and those that will not during ex vivo machine perfusion in ECD livers, which are superior to established criteria (Groeningen and Viability testing and transplantation of marginal livers (VITTAL) criteria)). The primary endpoint is microdialysis lactate level between donor livers after 4 hours of normothermic machine perfusion in ECD livers.
The follow-up period is 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single center, prospective, open, observational study
| Arm | Type | Receives |
|---|---|---|
| Liver transplanted patient | Active comparator | Procedure: Liver transplantationPatients who are transplanted with an ECD liver after pretreatment with a liver perfusion machine |
| Non-liver transplanted patient | No intervention | –Patients who are not offered a liver transplantation during the inclusion period |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Signed informed consent
- ≥ 18 years
- Indication for liver transplantation (one criteria must be met):
- Colorectal cancer patients who have received 1st and 2nd line chemotherapy where the treatment has been stopped due to progression or toxicity and the patient is not eligible for SECA-2 (Survival Following Liver Transplantation for Patients With Nonresectable Liver-only Colorectal Metastases) study.
- Hepatocellular carcinoma patients who are not suitable for standard liver transplantation, liver resection or local treatment (Transarterial Chemoembolisation or Selective internal radiotherapy). The patients must have progression or intolerance (toxicity) for immune checkpoint inhibitors or 1st line treatment.
Key exclusion criteria (4 listed)
- Already listed for ordinary Ltx with expectance of getting offered a regular liver graft within a reasonable time-frame.
- Patients included in the control arm of the SECA-3 study or the Excalibur studies except for the Ltx arm of the Excalibur I study.
- Mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial.
- Any reason why, in the opinion of the investigator, the patient should not participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver transplantationPatients who receive an ECD liver after an ex-vivo liver perfusion where the liver has been tested for function and approved according to international functional criteria (Groeningen criteria) | Procedure or surgery | Liver transplanted patient |
Primary outcome
Lactate level in microdialysate from hilar plate after normothermic machine perfusion - 4 hours
Time frame: 4 hours
Lactate level in microdialysate from hilar plate after normothermic machine perfusion in extended criteria donors livers.
303 secondary outcomes
Lactate level in microdialysate from liver tissue after normothermic machine perfusion - 2.5 hours
Time frame: 2.5 hours
Lactate level in microdialysate from liver tissue after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
Time frame: 2 hours
Pyruvate level in microdialysate from liver tissue after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
Time frame: 2 hours
Glycerol level in microdialysate from liver tissue after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
Time frame: 2 hours
Glucose level in microdialysate from liver tissue after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
Time frame: 2 hours
Lactate level in microdialysate from liver tissue after controlled oxygenated rewarming machine perfusion - 1 hour
Time frame: 1 hour
Glycerol level in microdialysate from liver tissue after controlled oxygenated rewarming machine perfusion - 1 hour
Time frame: 1 hour
Glucose level in microdialysate from liver tissue after controlled oxygenated rewarming machine perfusion - 1 hour
Time frame: 1 hour
Pyruvate level in microdialysate from liver tissue after controlled oxygenated rewarming machine perfusion - 1 hour
Time frame: 1 hour
Glucose level in microdialysate from liver tissue after normothermic machine perfusion - 2.5 hours
Time frame: 2.5 hours
Glucose level in microdialysate from liver tissue after normothermic machine perfusion - 4 hours
Time frame: 4 hours
Pyruvate level in microdialysate from liver tissue after normothermic machine perfusion - 2.5 hours
Time frame: 2.5 hours
Pyruvate level in microdialysate from liver tissue after normothermic machine perfusion - 4 hours
Time frame: 4 hours
Glycerol level in microdialysate from liver tissue after normothermic machine perfusion - 2.5 hours
Time frame: 2.5 hours
Glycerol level in microdialysate from liver tissue after normothermic machine perfusion - 4 hours
Time frame: 4 hours
Lactate level in microdialysate from bile after normothermic machine perfusion - 4 hours
Time frame: 4 hours
Lactate level in microdialysate from bile after normothermic machine perfusion - 2.5 hours
Time frame: 2.5 hours
Glucose level in microdialysate from bile after normothermic machine perfusion - 4 hours
Time frame: 4 hours
Glucose level in microdialysate from bile after normothermic machine perfusion - 2.5 hours
Time frame: 2.5 hours
Pyruvate level in microdialysate from bile after normothermic machine perfusion - 4 hours
Time frame: 4 hours
Pyruvate level in microdialysate from bile after normothermic machine perfusion - 2.5 hours
Time frame: 2.5 hours
Glycerol level in microdialysate from bile after normothermic machine perfusion - 4 hours
Time frame: 4 hours
Glycerol level in microdialysate from bile after normothermic machine perfusion - 2.5 hours
Time frame: 2.5 hours
Glycerol level in microdialysate from bile after controlled oxygenated rewarming machine perfusion - 1 hour
Time frame: 1 hour
Glucose level in microdialysate from bile after controlled oxygenated rewarming machine perfusion - 1 hour
Time frame: 1 hour
Lactate level in microdialysate from bile after controlled oxygenated rewarming machine perfusion - 1 hour
Time frame: 1 hour
Pyruvate level in microdialysate from bile after controlled oxygenated rewarming machine perfusion - 1 hour
Time frame: 1 hour
Pyruvate level in microdialysate from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
Time frame: 2 hours
Glycerol level in microdialysate from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
Time frame: 2 hours
Lactate level in microdialysate from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
Time frame: 2 hours
Glucose level in microdialysate from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
Time frame: 2 hours
Bile gases pH - 4 hours after normothermic machine perfusion
Time frame: 4 hours
Bile gases pH - 2.5 hours after normothermic machine perfusion
Time frame: 2.5 hours
Bile gases Lactate - 4 hours after normothermic machine perfusion
Time frame: 4 hours
Bile gases Lactate - 2.5 hours after normothermic machine perfusion
Time frame: 2.5 hours
Bile gases Glucose - 4 hours after normothermic machine perfusion
Time frame: 4 hours
Bile gases Glucose - 2.5 hours after normothermic machine perfusion
Time frame: 2.5 hours
Bile gases Oxygen (O2) - 4 hours after normothermic machine perfusion
Time frame: 4 hours
Bile gases O2 - 2.5 hours after normothermic machine perfusion
Time frame: 2.5 hours
Bile gases carbon dioxide (CO2) - 4 hours after normothermic machine perfusion
Time frame: 4 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Individual participant dataSharing planned: No. Due to Norwegian laws individual participant data are not shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Søren E Pischke, MD, PhD principal investigator
Oslo University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Liver transplantation in people with Liver Transplant; Complications and Transplant; Failure, Liver, run by Oslo University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Søren E Pischke, MD, PhD (45486579 ext. +47, s.e.pischke@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lactate level in microdialysate from hilar plate after normothermic machine perfusion - 4 hours (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.